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Feasability study of Enhanced Relapse Prevention (ERP) delivered by Care Coordinators (CCs) to people with Bipolar Disorder (BD) - a cluster randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN41352631
Enrollment
120
Registered
2005-10-07
Start date
2005-01-10
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder (Type I and II) Mental and Behavioural Disorders Bipolar disorder

Interventions

ERP versus TAU 1. A training package for ERP delivered to CCs who are part of Community Mental Health Teams (CMHTs) and who have current active caseloads of people with BD. The training will include

Sponsors

The University of Liverpool (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Lifetime diagnosis of Bipolar Disorder (I or II) 2. Two or more relapses ever and at least one in the last year or two in the last 3 years 3. Currently in contact with healthcare professional attached to a CMHT 4. Working understanding of English language

Exclusion criteria

Exclusion criteria: 1. Substantial cognitive impairment, i.e. moderate/severe learning disability 2. Drug/alcohol abuse/dependence a primary diagnosis, i.e people who use drugs/alcohol are not excluded unless the severity of this would make them unable to engage with the intervention 3. No working understanding of the English language

Design outcomes

Primary

MeasureTime frame
1. The effectiveness of the training intervention with CCs assessed by training and CC ratings 2. An estimate of the effect size of the ERP intervention by CCs will be made by comparing patients receiving ERP with those receiving treatment as usual on: a. Time to recurrence to an episode of illness of sufficient severity to reach Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for major depressive, manic, or mixed episode, based on the Structured Clinical Interview for Depression (SCID) interview b. Assessment of coping using the Coping with Manic and Depressive Prodromes checklist c. The Client Service Receipt Schedule (CSRI) to estimate the use of primary, inpatient, outpatient, day patient, community and emergency services The feasibility will be assessed using quantitative and qualitative data. Quantitative data: 1. Recruitment rates of CMHTs: proportion of teams approached who agreed to take part 2. Attendance rates: the number of training and supervision sessions attended by each care coordinator 3. Care coordinator feedback ratings of training and supervision 4. Service user recruitment rates: number of service users recruited within each group - ERP and TAU 5. Service user retention rates: number of service users that completed follow-up at each point 6. Number of relatives taking part (ERP only) Qualitative data: 1. Interview feedback from care coordinators (ERP and TAU) 2. Feedback from service users and relatives (ERP only) identifying barriers to the intervention. An estimate of the effect size of the intervention will be made using time from baseline to recurrence of an episode of major depression , hypomania, mania, or mixed, satisfying DSM-IV criteria, as the main outcome. All outcomes will be reported allowing for design effect.

Secondary

MeasureTime frame
1. Longitudinal analysis of symptom severity using the Longitudinal Interval Follow-up Evaluation (LIFE-II) modified to DSM criteria 2. An estimate of recruitment and drop-out rates 3. Qualitative interviews to gather detailed information from CCs of their experience of training and offering ERP, and from patients with BD and their friends/relatives of their experience of therapy

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026